Regulatory
The agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease.
The action data was extended by the agency to provide more time to review new data analyses submitted by Lilly, per information requests made by the FDA.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 6, 2021.
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
The U.S. FDA issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.
If you’re one of the 17% of Americans that have been fully vaccinated against SARS-CoV-2, you are probably feeling some level of relief. But the CDC warns not to throw your mask away just yet.
Sepsis is among the best-known and least effectively treated conditions in the modern world. The standard of care has failed for these infections, leaving the U.S. healthcare system with $62 billion and 270,000 deaths annually. Globally, 11 million die from sepsis each year. Effective drugs and diagnostics are available. They’re just not used.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.
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